LA JOLLA, Calif., Aug. 26 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) announced that data were presented at The European Tissue
Repair Society in Bordeaux, France, indicating that Dermagraft(R) stimulates
new blood vessel formation, or angiogenesis, both in the laboratory and in
diabetic foot ulcer patients. Adequate blood flow to damaged tissue is a
vital part of the wound healing process. These studies are consistent with
data previously reported by the Company investigating Dermagraft's role in
wound healing and its potential for inducing new blood vessel formation.
Scientists and clinicians working in the Section of Vascular Medicine and
Biology and the Diabetes Centre at University of Dundee Medical School,
Scotland, presented, "Blood Flow Changes in Diabetic Foot Ulcers Treated with
Dermagraft." In their study they observed approximately a 75% increase
(p<0.001) in blood flow at the base of diabetic foot ulcers treated for eight
weeks with Dermagraft. Five of the seven wounds studied had healed by twelve
weeks, and the other two had markedly reduced in size. The increase in blood
flow was measured using laser Doppler imaging to study microvascular passage
of blood at the base of the foot ulcers. The group indicated that the
improvement in blood flow may reflect angiogenesis in the healing wound,
possibly enhanced by a sustained and appropriate supply of angiogenic growth
factors provided by Dermagraft.
Scientists from the Wound Healing Research Unit, University of Wales
College of Medicine, Cardiff, presented data showing that human vascular
endothelial cells co-cultured with Dermagraft increased the release of
specific proteins believed to be important in angiogenesis. Vascular
endothelial cells are cells which line the interior of blood vessels.
Specifically, it was reported that Dermagraft significantly influenced the
expression of VE (vascular endothelial) cadherin and beta catenin.
Dr. David Newton, Ph.D., Research Fellow in Vascular Medicine and Biology
at University of Dundee Medical School, commented, "Angiogenesis is a vital
part of the wound healing process in diabetic foot ulcers and requires a
finely balanced environment for success. An advantage of Dermagraft is that
it may help maintain that balanced environment." Professor Keith Harding, MB,
MRCGP, FRCS, Professor of Rehabilitation Medicine (Wound Healing) at Cardiff,
added, "In developing new technologies for the treatment of chronic wounds, it
is important to understand their mechanism of action. The results from my own
group and those in Dundee, taken together, may help explain in the laboratory,
as well as in the patient, one crucial component of the potential benefit
offered by Dermagraft."
Advanced Tissue Sciences is a tissue engineering company utilizing its
proprietary core technology to develop and manufacture human-based tissue
products for tissue repair and transplantation. The Company has two joint
ventures with Smith & Nephew. The first covers the application of Advanced
Tissue Sciences' tissue engineering technology for skin wounds and includes
Dermagraft(R) for the treatment of diabetic foot ulcers, TransCyte(TM) for the
temporary covering of second and third-degree burns and future developments
for venous ulcers, pressure ulcers, burns and other non-aesthetic wound care
treatments. The second joint venture is developing tissue-engineered
orthopedic cartilage, initially focusing on the repair of cartilage in knee
joints. The Company also has a strategic alliance with Inamed Corporation for
the development and marketing of several of Advanced Tissue Sciences'
human-based, tissue-engineered products for aesthetic and certain
reconstructive applications. The Company is also developing products for
cardiovascular applications.
The discussion contained in this press release relating to research,
development, or commercialization of the Company's products involves certain
risks and uncertainties. In particular, the Company will need to successfully
complete an additional controlled clinical trial for Dermagraft in the
treatment of diabetic foot ulcers and submit a revised premarket approval
application to the FDA prior to commercially marketing Dermagraft for that
indication. The Company may not successfully complete the additional clinical
trial, the clinical trial may not be completed within any specific timeframe,
the data from the trial may not be statistically significant or otherwise
consistent with the results of the Company's earlier pivotal trial. The
Company may not obtain FDA or other regulatory approvals of Dermagraft or any
other products at all or on a timely basis, scale up manufacturing processes,
or successfully commercialize any such products. These and other risks are
detailed in publicly available filings with the Securities and Exchange
Commission such as the Company's Annual Report on Form 10-K for the year ended
December 31, 1998 and the Company's most recent Registration Statement on Form
S-3 filed on July 12, 1999, as amended. Actual results may differ materially
from those currently anticipated as a result of such risks.
SOURCE Advanced Tissue Sciences, Inc.
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CONTACT:
Beth Kriegel, Senior Director, Financial
Planning and Analysis of Advanced Tissue Sciences, Inc.,
858-713-7991
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